WASHINGTON (dpa-AFX) - Geron Corporation (GERN), a commercial-stage biopharmaceutical company, Friday said that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the approval of RYTELO for the treatment of transfusion-dependent anemia due to lower risk myelodysplastic syndromes (LR-MDS), a type of blood cancer.
The positive recommendation was based on positive results from IMerge Phase 3 study, in which patients treated with RYTELO reduced the need for red blood cell transfusions compared to placebo.
The European Commission is expected to make a final decision on the marketing authorization application in the following months. The Drug is already approved by the FDA.
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